Company: Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report 5/18/2016
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Recall Number Z-1650-2016
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn’t meet the patient position description, when the scanner position was set to “Right” in the system setting – scanner options.
Neusoft Medical Systems Co., Ltd. , Shenyang China on 5/2/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US Distribution – Including Puerto Rico and the states of IL, CT, SC, NE